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Completed

NCT Number: NCT05139732

Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities

In functional neurological disorder (FND), neurological symptoms are present, such as paralysis, weakness and disturbed sensation of limbs, although clinically no abnormalities can be found. It is a poorly understood disorder with uncertain diagnosis, treatment and prognosis. In this study, the subtype functional paralysis is investigated with advanced neuroimaging techniques that go beyond standard clinical examinations. In previous research on FND, healthy volunteers have generally been used as a control group. However, since people with functional paralysis have similar symptoms to people with spinal cord injuries (SCI), it is intended to compare the three groups to find similarities and differences. With the proposed methods, the goal is to gain a detailed understanding of FND regarding nerve cell metabolism, diffusion pathways and neuronal networks involved in cognitive processes such as motor inhibition (reaction or no reaction depending on situation). Neurophysiological data, clinical assessments and questionnaires are carried out in addition to Magnetic Resonance Imaging (MRI).

The aim is to enrol 75 participants in this study, i.e. 25 people with FND, 25 people with SCI and 25 healthy control subjects.

The overall goal of the study is to find markers for FND for use in future studies to improve diagnosis and individualise therapy recommendation for both people with SCI and people with FND. Therefore, this study is a relevant step to understand FND and to diagnose this specific disease using objective MRI based diagnostic tools.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-65

Exclusion criteria

  • Contraindication for magnetic resonance examinations (e.g. cardiac pacemaker, pregnancy, etc.)
  • history of mental or neurological illness (addiction, central nervous system tumour and severe craniocerebral trauma)
  • unable to hold a pen due to paralysis

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Diagnostic Test

In order to investigate the metabolic profile, magnetic resonance spectroscopy (MRS) will be applied. Functional MRI (fMRI) allows to indirectly track cell activation measuring the blood-level dependent signal changes followed spontaneously (in resting state) or evoked by a task. Diffusion weighted imaging (DWI) is based on the differences in motion of the water molecules given by the underlying microarchitecture of the nervous tissue. Diffusion tensor imaging (DTI) allows visualisation of the nerve bundles and alterations thereof. Thus, microstructural alterations can be measured.

Other names: Functional Magnetic Resonance Imaging (fMRI), In-vivo Magnetic Resonance Spectroscopy (MRS), Diffusion Tensor Imaging (DTI), Diffusion Weighted Imaging (DWI)

Primary outcomes

  1. Nerve Cell Metabolism

    Time frame: day 1

    With MRS metabolites are examined specific for cell integrity (N-acetyl-aspartate), cell energy (creatine, lactate), and neurotransmitter (choline, glutamate and glutamine).

  2. Brain Functional Connectivity

    Time frame: day 1

    With fMRI in rest and task condition, the functional connectivity (FC) is examined. With that the functionally integrated relationship between spatially separated brain regions are investigated.

  3. Fiber tracts in three dimensional mapping

    Time frame: day 1

    DWI provides quantitative evaluations by measuring the apparent diffusion coefficient (ADC) and fractional anisotropy (FA), which are scalars of isotropic and anisotropic diffusion. Diffusion tensor imaging (DTI) analyses the three-dimensional shape of the diffusion, also known as diffusion tensor. So, it is used to characterize the magnitude, the degree of anisotropy, and the orientation of directional diffusion of white matter.

Secondary outcomes

  1. Satisfaction with Life Scale questionnaire

    Time frame: day 1

    Likert Scale of 1 (strong disagreement) -7 (strong agreement); 5 Questions in total

  2. Hospital Anxiety and Depression Scale questionnaire

    Time frame: day 1

    Likert Scale of 1 (strong disagreement) -4 (strong agreement); 14 Questions in total

  3. Numerical Rating Scale (NRS) questionnaire

    Time frame: day 1

    Rating the pain on a likert scale of 0 (no pain) -10 (insupportable pain)

  4. Sensibility testing according to International Standards for Neurological Classification of SCI (ISNCSCI)

    Time frame: day 1

    A key point in each of the 28 dermatomes is tested bilaterally using light touch and pin-prick (sharp-dull discrimination). A three-point scale is used for scoring:

    0 = absent

    • = altered (impaired or partial appreciation, including hyperesthesia)
    • = normal or intact (similar as on the cheek) not testable

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2021
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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